Ventriculae Tachycardia Ventriculae Tachycardia
Conditions
Interventions
There are no product or intervention under research, since the two procedure investigated in this study are being used by the current clinical practice.
Sponsors
IRCCS San Raffaele Hospital
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with an implanted ICD (all brands) - Patients who underwent a successful (non-inducibility of any VT) Ventricular Tachycardia Ablation procedure, the “index procedure”, supported by EnSite Precision or CARTO 3D mapping systems for the following etiologies: previous MI, myocarditis, ARVD, IDCM. - Age 18 years or more - Able to provide an informed consent to participate to the study and available to respect the assessments described in the protocol.
Exclusion criteria
Exclusion criteria: Inducible VT after index procedure - Contraindication to anticoagulants - Presence of thrombi - Presence of Mitral and Aortic prosthetic valve - Recent (<3 months) myocardial infarction or unstable angina or Coronary Artery Bypass - Pregnant or nursing - Ventricular Tachycardia caused by reversible pathology - < 1 Year life expectancy according to the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the rate of ventricular tachycardia recurrence within 12 months in ICD patients undergoing a Re-Do ventricular tachycardia ablation compared to patients treated with antiarrhythmic drug therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of ICD shocks. 2. Proportion of patients with VT storm. 3. Rate of subsequent hospitalization for VT recurrence/HF. 4. Cardiac mortality. 5. NIPS predictive value for VT recurrence. 6. Complications of both treatment groups | — |
Countries
Germany, Italy, Netherlands, Spain
Contacts
Public ContactLeila Kalantari
ALEPH srl
Outcome results
None listed